MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC BAND AID BRAND KPP (KIZU POWER PAD) BANDAGES; DRESSING, WOUND, OCCLUSIVE

Model Number 4901730021906

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Skin Infection (4544); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/03/2023

Event Type  Injury  

Manufacturer Narrative

Johnson & johnson consumer, inc.Is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which johnson & johnson consumer, inc.Has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, johnson & johnson consumer, inc.Or its employees that the report constitutes an admission that the device, johnson & johnson consumer, inc., or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.Patient age, gender, weight, ethnicity and race were not available for reporting.This report is for one band aid brand kizu power pad (kpp) regular 10ct ap 4901730021906 4901730021906apb 4901730021906apb, lot number 0972c.Device is not distributed in the united states but is similar to device marketed in the usa (band aid brand hydroseal bandages all purpose 1ct usa 381371175338 8137117533usa 8137117533usa).Udi #: concomitant medical products: upc #: 4901730021906.Expiration date: jan-20-2025.Lot #: 0972c.Concomitant medical products: device is not expected to be returned for manufacturer review/investigation.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.A review of the device history records has been requested.(b)(4).This is one of two medwatches being submitted as two devices were involved in this event.See medwatch 2214133-2023-00005 bab#02 for an internal hemorrhage part without wounds:.The same patient is represented in each medwatch.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The consumer reported an event with band aid brand regular kizu power pads (kpp).Consumer fell to the ground and injured a little finger on (b)(6) 2023.As recommended by pharmacist, the consumer applied the band aid to two sites, a wounded part and an internal hemorrhage part without wounds, on (b)(6) 2023.The consumer stated that the device peeled off easily when was soaked in the water.Therefore, to prevent the device from peeling off while taking a bath, consumer applied an adhesive bandage manufactured by another company over the (kpp) device.The wound started to form pus on (b)(6) 2023, but the consumer continued applying the device while changing strips and the wound appeared to be getting worse.As reported by consumer, wound became infected.Consumer consulted a pharmacist and was told to stop using the device and apply an antibiotic (details not reported, route interpreted as topical) because the wound could not be cured with the product anymore.As for internal hemorrhage part, it was not cured, and the skin peeled off (interpreted as skin tear).According to the pharmacist¿s instruction, the consumer stopped using the device and applied antibiotic (details not reported, route interpreted as topical).This is one of two medwatches being submitted as two devices were involved in this event.See medwatch 2214133-2023-00005 bab#02 for an internal hemorrhage part without wounds.The same patient is represented in each medwatch.

Manufacturer Narrative

Johnson & johnson consumer, inc.Is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which johnson & johnson consumer, inc.Has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, johnson & johnson consumer, inc.Or its employees that the report constitutes an admission that the device, johnson & johnson consumer, inc., or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.H4, h6: device history records review was completed.No non-conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition and product was manufactured per specification.The product was manufactured on february 21, 2022.This is one of two follow up medwatches being submitted as two devices were involved in this event.The same patient is represented in each follow up medwatch.If information is obtained that was not available for the follow-up #1 medwatch, an additional follow- up medwatch will be filed as appropriate.

Manufacturer Narrative

Johnson & johnson consumer, inc.Is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which johnson & johnson consumer, inc.Has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, johnson & johnson consumer, inc.Or its employees that the report constitutes and admission that the device, johnson & johnson consumer, inc., or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.Corrected data: follow up (01) - type of investigation - update from b17 to b14.Additional data: b5- additional verbatim this is one of two follow up medwatches being submitted as two devices were involved in this event.See medwatch 2214133-2023-00005 bab#02 for an internal hemorrhage part without wounds.The same patient is represented in each medwatch.If information is obtained that was not available for the follow-up (02) medwatch, a follow-up (03) medwatch will be filed as appropriate.

Event Description

Consumer reported that they visited a hospital and had the wound cut to get rid of the pus.As per consumer, it took about a month till the wound resolved.This is one of two medwatches being submitted as two devices were involved in this event.See medwatch 2214133-2023-00005 bab#02 for an internal hemorrhage part without wounds.The same patient is represented in each medwatch.

• Brand Name: BAND AID BRAND KPP (KIZU POWER PAD) BANDAGES
• Type of Device: DRESSING, WOUND, OCCLUSIVE
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER INC; 199 grandview road; skillman NJ 08558 9418
• Manufacturer (Section G): COLOPLAST; coloplast hungary kft.; h-4300 nyirbator; coloplast u.2 ; HU
• Manufacturer Contact: laurie rauco ; 199 grandview rd; skillman, NJ 08558-9418 ; 2152734905
• MDR Report Key: 16207270
• MDR Text Key: 307716609
• Report Number: 2214133-2023-00004
• Device Sequence Number: 1
• Product Code: NAD
• UDI-Device Identifier: 4901730021906
• UDI-Public: (01)4901730021906(17)250120(10)0972C
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 4901730021906
• Device Lot Number: 0972C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 01/05/2023
• Initial Date FDA Received: 01/19/2023
• Supplement Dates Manufacturer Received: 01/23/2023; 02/21/2023
• Supplement Dates FDA Received: 02/02/2023; 03/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2022
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention